EMA — authorised 17 May 2024
- Application: EMEA/H/C/005764
- Marketing authorisation holder: Novartis Europharm Limited
- Local brand name: Fabhalta
- Indication: Paroxysmal nocturnal haemoglobinuria Fabhalta is indicated as monotherapy in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia. Complement 3 glomerulopathy Fabhalta is indicated for the treatment of adult patients with complement 3 glomerulopathy (C3G) in combination with a renin-angiotensin system (RAS) inhibitor, or in patients who are RAS-inhibitor intolerant, or for whom a RAS inhibitor is contraindicated (see section 5.1).
- Pathway: orphan, PRIME
- Status: approved
The European Medicines Agency (EMA) has granted marketing authorisation for Fabhalta, a treatment for two rare blood disorders. Fabhalta is indicated for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH), a condition characterised by the destruction of red blood cells. It is also approved for the treatment of complement 3 glomerulopathy (C3G), a kidney disease, in combination with a renin-angiotensin system (RAS) inhibitor or in patients who are intolerant to RAS inhibitors. The marketing authorisation holder is Novartis Europharm Limited.